Registry for monitoring RSV vaccine effects during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to assess the risks of adverse pregnancy outcomes, such as preterm birth and hypertensive disorders, following exposure to the RSV vaccine during late pregnancy (between 32 and 36 weeks of gestation). The study will collect data on various maternal and neonatal outcomes to evaluate the safety of the vaccine in this specific population. Participants will include pregnant individuals who have received the RSV vaccine within the specified gestational period, and the registry will track their health outcomes and any complications that may arise. The findings will help inform the safety profile of the RSV vaccine for pregnant individuals and their infants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals must meet the following inclusion criteria to be eligible for inclusion in the study:

  1. A resident of the US at enrollment
  2. 18 to 50 years of age at enrollment
  3. Gestational age of ≥32 weeks, 0 days at enrollment
  4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
  5. Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
  6. Authorization obtained for the relevant HCP(s) to provide data to the registry
  7. Contact information available (for participant and HCPs)

Exclusion Criteria:

* Individuals meeting any of the following criteria will not be included in the study:

  1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation
  2. Multi-fetal pregnancy
  3. Enrolled in the RSV-PR with a previous pregnancy

Where it's running

• Ppd
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ronna Chan, PhD, MPH — PPD, Part of Thermo Fisher Scientific
• Study coordinator: Ronna Chan, PhD, MPH
• Email: RSV@corevitas.com
• Phone: 1-800-616-3791

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.